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Flexion-Extension Radiograph Imaging Protocol Reliability Study

NCT05633550 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-09-11

No results posted yet for this study

Summary

Orthopedic surgeons often face the dilemma of whether to add fusion to a decompression procedure of the spine. Their decision mainly relies on personal experience to determine if a level is unstable preoperatively or if a specific decompression procedure might destabilize the spine. Lumbar spine flexion-extension radiographs aim to provide clinicians with images to assess the dynamism of a vertebral level, which crucial for evaluating spinal instability. However, the lack of a standardized imaging protocol for taking such flexion-extension radiographs leads to wide variability in their quality. This impacts the efficacy of radiographic measurements of angular and translational motion used for diagnosis. To effectively and reliably diagnose instability, it is crucial to control and standardize the flexion-extension radiograph protocols to promote the repeatability of intervertebral motion that characterizes a patient's full range of motion. The objective of this study is to evaluate the test-retest reliability of a standardized flexion - extension radiograph imaging protocol for the lumbar spine. This is an exploratory reliability study. A non-probability purposive sample of 45 patients with back pain from two tertiary care hospitals in The Netherlands is used. There is bo intervention. The main study parameter/endpoint is the agreement between the participants' first ("test") and second ("retest") kinematic results from their lumbar flexion-extension radiographs.

Conditions

  • Lumbar Spinal Stenosis
  • Spinal Instability

Interventions

DIAGNOSTIC_TEST

Flexion-extension radiographs

Participants will undergo (regular) flexion-extension radiographs.

Sponsors & Collaborators

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Job LC van Susante, Dr. PhD. · Department of orthopedics, Rijnstate Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2025-08-25
Completion
2026-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633550 on ClinicalTrials.gov